Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-Treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial

Publication date: Available online 7 December 2017
Source:Clinical Therapeutics
Author(s): Chee Hae Kim, Kyung Ah Han, Jaemyung Yu, Sang Hak Lee, Hui Kyung Jeon, Sang Hyun Kim, Seok Yeon Kim, Ki Hoon Han, Kyungheon Won, Dong-Bin Kim, Kwang-Jae Lee, Kyungwan Min, Dong Won Byun, Sang-Wook Lim, Chul Woo Ahn, SeongHwan Kim, Young Joon Hong, Jidong Sung, Seung-Ho Hur, Soon Jun Hong, Hong-Seok Lim, Ie Byung Park, In Joo Kim, Hyoungwoo Lee, Hyo-Soo Kim
PurposeThe purpose of this study was to examine the efficacy and safety of adding ω-3 fatty acids to rosuvastatin in patients with residual hypertriglyceridemia despite statin treatment.MethodsThis study was a multicenter, randomized, double-blind, placebo-controlled study. After a 4-week run-in period of rosuvastatin treatment, the patients who had residual hypertriglyceridemia were randomized to receive rosuvastatin 20 mg/d plus ω-3 fatty acids 4 g/d (ROSUMEGA group) or rosuvastatin 20 mg/d (rosuvastatin group) with a 1:1 ratio and were prescribed each medication for 8 weeks.FindingsA total of 201 patients were analyzed (mean [SD] age, 58.1 [10.7] years; 62.7% male). After 8 weeks of treatment, the percentage change from baseline in triglycerides (TGs) and non–HDL-C was significantly greater in the ROSUMEGA group than in the rosuvastatin group (TGs: −26.3% vs −11.4%, P < 0.001; non–HDL-C: −10.7% vs −2.2%, P = 0.001). In the linear regression analysis, the lipid-lowering effect of ω-3 fatty acids was greater when baseline TG or non−HDL-C levels were high and body mass index was low. The incidence of adverse events was not significantly different between the 2 groups.ImplicationsIn patients with residual hypertriglyceridemia despite statin treatment, a combination of ω-3 fatty acids and rosuvastatin produced a greater reduction of TGs and non−HDL-C than rosuvastatin alone. Further study is needed to determine whether the advantages of this lipid profile of ω-3 fatty acids actually leads to the prevention of cardiovascular event. ClinicalTrials.gov identifier: NCT03026933.



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